Dear Sir I write to set out the Trust’s response to the learned Coroner’s Regulation 28 Prevention of Future Deaths Report dated 16 November 2021. It is noted that the Coroner conducted an investigation into the death of Sharon-Anne Robinson and concluded the inquest with the medical cause of death being recorded as: 1a Hypoxic Brain Injury 1b Cardiac Arrest 1c Treated chest infection (with amoxicillin anaphylaxis) It is noted that the inquest was concluded with a narrative conclusion which states that: “Sharon Robinson died on the 7th February, 2019 at Airedale Hospital as a result of administration of an antibiotic on the 27 January which induced an anaphylactic reaction.” It is further noted that the Coroner sets out his concern in the PFD report as follows: “There is a concern that when a patient may have a sensitive [sic] to anti-biotic despite the low risk, this will be ignored and anti-biotic be given in any event.” I would firstly like to pass on my sincere condolences to Mrs Robinson’s family for their loss and to make clear that we have taken this case very seriously and wish to learn as much as we can from these tragic events. We started this process off when we conducted an internal investigation into the death and, at the time, set out a series of actions in response which were included in the Trust’s Serious Incident Report dated 30th April 2019. This report was submitted to the CCG and confirmation received in relation to the subsequent review of learning and actions. I would then like to address the suggestion that a patient’s sensitivity to an antibiotic would be ‘ignored’ and an antibiotic given in any event. In the case of Mrs Robinson, the Trust’s evidence given at inquest was that Mrs Robinson’s recorded allergy to Penicillin was not ‘ignored’. It was carefully considered when the treating clinician exercised their clinical decision making around whether or not it would be appropriate and safe to administer Amoxicillin (Penicillin-based antibiotic) for a Lower Respiratory Tract Infection (‘LRTI’) in January 2019. The Trust’s evidence was that, before deciding to prescribe Amoxicillin, the patient had reported to clinical staff that, notwithstanding the ‘allergy alert’ on her file, she

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had successfully been treated with Amoxicillin on many previous occasions without any adverse reaction. The treating clinician was able to corroborate this point by reference to medical records (as recent as September 2018), which confirmed that Mrs Robinson had been discharged on a course of Amoxicillin for the same clinical condition and had reported no adverse reaction to the same. It was the Trust’s evidence that whilst a medication allergy should always be elicited, recorded and carefully considered, it is right to explore the nature of an allergy (signs, symptoms and severity) in line with NICE guidance CG183. This is even more so in circumstances where the condition in question is best treated by the antibiotic subject to the allergy alert, as was the situation in Mrs Robinson’s case. The Trust’s evidence at inquest was that allergies are often relative, stem from childhood, are often not experienced again in later life and do not always pose a major threat.

I thought it was appropriate to make it plain in this response that this was not a case of the treating clinician prescribing a medication in ignorance of an allergy. It is a case where a conscious decision was made to administer the Amoxicillin to the patient after it had been confirmed by the patient that she had not suffered any adverse reaction to Amoxicillin over many years, which, as I have set out, was corroborated by reference to her medical records stating over 40 courses of penicillin-based antibiotics prescribed in the community since
2003. [It is also a case that the Trust’s antimicrobial policy was followed by the treating clinician in relation to antibiotic choice and the allergy history.]

It would, therefore, appear to me that the Coroner’s concern is targeted at whether or not it is appropriate to administer an antibiotic to a patient in the presence of a known or suspected allergy to an ingredient within that particular antibiotic in any circumstances, and this is therefore the primary point we have sought to consider and address as an organisation, in order to provide some assurance to ourselves and the learned Coroner.

In order to do so, I am pleased to report on some of the activities which have taken place since receipt of the Regulation 28 PFD report, as follows:

• Case discussed at the Senior Medical Leadership Group meeting. This includes all Clinical Directors and Divisional Medical Directors within Airedale NHS Foundation Trust.

• Case discussed at the Bradford District and Craven Medical Directors Meeting – this is an external meeting and the purpose of discussing the case in this forum was to ascertain a wider view which encompasses other Acute, Mental Health and Community Trust and Primary Care medical directors – so a wide audience to test the thinking and challenges this poses in ensuring each patient is assessed on their merit and there is a consistent approach across Bradford & Airedale.

• Chief Pharmacist and Executive Medical Director are working to align the approach for Bradford Teaching Hospitals and Airedale Hospitals, which will be overseen by the Drug and Therapeutics Committee. This includes revision of the Antimicrobial Policy – to build in best evidence-based practice with experts to implement safe patient care.

 The Chief Pharmacist sits on regional fora in West Yorkshire and Harrogate where again the Trust approach is being considered.

 The Trust Antimicrobial Pharmacist has discussed this case at the Yorkshire and Humber Antimicrobial Pharmacists Network. The Trust recognises the Coroner’s concern that there is a risk of a prescription of a medication to a patient where there is a documented allergy. In wider discussions with senior clinicians within and outwith the Trust, it has also heard a concern that there are

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circumstances in which allergies are recorded inaccurately in relation to medication side effects (such as due to nausea/ diarrhoea) and where a risk based discussion (clearly documented and made at senior level) might be appropriate, and prevents the exceptional circumstance in which a medication might be withheld and alternatives may be non-existent or have more intrinsic risks of other toxicities.

The Trust is, therefore, seeking ongoing wider engagement with other healthcare providers to understand how this risk is effectively managed in those organisations and ensuring that HM Coroner’s recommendations are visible in their own organisations.

I do hope that the information provided in this response has been of help and that it sets out in context the thought processes surrounding and actions taken in response to this clinical incident. I will update HM Coroner in relation to the update of our Antimicrobial Policy, once the wider alignment with acute Trusts is concluded.